Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. However, stakeholders should be aware that the leaked review contains no such analysis.

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Drug Target Review

APRIL 9, 2024

Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

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Drug Discovery World

AUGUST 5, 2022

Ian Hollingsworth, Associate Director of product development at Boyds, the global drug development consultancy, explains the benefits to the drug development lifecycle of building strong partnerships with external consultants, and when and how to get the best from them. Why sponsors use external consultants.

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The Pharma Data

AUGUST 17, 2021

An experienced leader in drug development who has led and grown Lilly’s oncology business over the past several years, White will be responsible for Lilly’s launched products and Phase 3 portfolio in pain and neurodegeneration, including the potential launch of donanemab for the treatment of Alzheimer’s disease.

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Drug Discovery World

AUGUST 3, 2023

There are also three synthetic cannabis-related drug products, which are Marinol (dronabinol), Syndros (dronabinol), and Cesamet (nabilone). Even still, these approved drug products require a licensed healthcare provider’s prescription. Examples of people on the Power List include Susan Audino in the Analytical Heroes category.

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Join the club.

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The Pharma Data

JANUARY 27, 2021

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. (Nasdaq: CASI), a U.S. About BioInvent.

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

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Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. The following PDUFA dates were obtained from publicly available sources.

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Codon

FEBRUARY 13, 2024

Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Nearly three million drug-resistant infections occur annually in the U.S.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Importantly, midomafetamine was proposed for use in conjunction with psychotherapy.

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The Pharma Data

DECEMBER 8, 2020

Since partnering with Eli Lilly to produce the first monoclonal antibody therapy approved for mild-to-moderate COVID-19 patients, antibody discovery company AbCellera is going big on the Nasdaq. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost. Silverback Therapeutics

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

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The Pharma Data

NOVEMBER 3, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA). About LogicBio Therapeutics. LogicBio is headquartered in Lexington, Mass.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

JUNE 2, 2023

By harmonizing with the International Electrotechnical Commission, this rule will decrease the regulatory burden on industry and allow the Agency to take advantage of the expertise of the international committees, thereby also saving resources.

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The Pharma Data

AUGUST 30, 2021

Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “As The international study was conducted at 46 sites in eight countries 8,9. The international study was conducted at 70 sites in seven countries 9 ,10. a statin or ezetimibe). a statin and/or ezetimibe). About Leqvio ® (inclisiran).

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Drug Discovery World

OCTOBER 10, 2022

Will an expansion in the use of effective digital biomarkers help improve the productivity of drug development in neuroscience? Increasingly, digital biomarkers are becoming more effectively used in the discovery and development of drugs that act in the central nervous system.

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The Pharma Data

JANUARY 24, 2021

25, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that U.S. SHANGHAI, China, Jan.

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The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

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The Pharma Data

NOVEMBER 29, 2020

Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance. Participants receive either pre-emptive or prophylactic antiviral therapy post-transplant and are followed for a 12-month observation period.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. We also market or plan to market in China additional oncology products licensed from Amgen Inc.,

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Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program.

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The Pharma Data

OCTOBER 26, 2020

billion related to certain license and collaboration agreements, and certain other items. Merck presented long-term findings from the EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA as adjuvant therapy in resected, high-risk stage III melanoma at the ESMO Virtual Congress 2020. Non-GAAP EPS of $1.74

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The Pharma Data

AUGUST 29, 2020

Inclisiran is currently under review by the FDA and the EMA for the treatment of primary hyperlipidemia (including Heterozygous Familial Hypercholesterolemia) in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy. Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis.

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Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

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The Pharma Data

SEPTEMBER 8, 2020

About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

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The Pharma Data

SEPTEMBER 8, 2020

(LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Cambridge, UK.

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Codon

SEPTEMBER 29, 2024

It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either. A flurry of new, promising therapeutic targets arose.

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The Pharma Data

NOVEMBER 5, 2020

Lastly, we are proud that our novel antibody cocktail REGN-EB3 recently became the first FDA-approved treatment for Ebola, underscoring the potential of antibody therapies to address deadly infectious diseases.” REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Corporate and Business Development Update.

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Agency IQ

MAY 10, 2024

For example, NIST and FDA are currently working on a project to develop consensus standards for regenerative medicines, the first batch of which were released in December 2023. The agencies have also worked together on topics such standardization in digital imaging and medical displays and cell and gene therapy manufacturing.

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Agency IQ

JULY 12, 2024

those sold under authorization from a licensed provider or other regulatory-specific situations) and is submitted as part of the medical device’s listing (general controls), and the agency may request a copy of all advertising materials for good cause ( See a Congressional Research Service explainer on this topic here ).

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The Pharma Data

NOVEMBER 15, 2020

This prestigious group of professionals will help lead the Company as it prepares for potential commercialization of its investigational cell therapy, MultiStem ®. She began her career as an investment banker at Nomura International Limited, from 1984-88, in Tokyo and London. and international experience.

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The Pharma Data

JANUARY 31, 2021

Gilead and Gritstone will develop an HIV-specific therapeutic vaccine using Gritstone’s proprietary prime-boost vaccine platform, comprised of self-amplifying mRNA (SAM) and adenoviral vectors, with antigens developed by Gilead. Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts.

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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The Pharma Data

DECEMBER 30, 2020

31, 2020 /PRNewswire/ — ImmVira Group Company (“the Company”), a biotechnology platform dedicated to the development of oncolytic virus(“OV”) and vector type approaches to create more effective and safer therapies against cancer, announced today the signing of Series C financing.

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Agency IQ

DECEMBER 1, 2023

Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig. The following PDUFA dates were obtained from publicly available sources.

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